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NCT07674654ClinicalTrials.gov

A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.

المرحلة 3مطلوب 1,000 مشارك113 موقعاًدولة واحدة

الفئات

طب الأعصاب100%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2026-06-29; recorded start 2026-08-03
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 4 other studies in this databaseCounted from the lead sponsor named in the record (Kallyope Inc.)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding16/20

    Triple-blind

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 115 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study: 1,000 participants (target), run at 113 sites.

How this score is built
  • Enrolment30/40

    1,000 participants (target)

  • Site count23/25

    115 sites

  • Country count7/15

    2 countries

  • Planned duration7/10

    Planned over about 23 months

  • Sponsor scale2/10

    Kallyope Inc. has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

ملخص

This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.

الحالات

  • Acute Migraine

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

Inclusion Criteria: 1. Participant completing an acute treatment trial of elismetrep (Study K-304 P003; attending the EoS Visit 3 within the allowed visit window of the acute treatment study), treated a qualifying migraine in that study, was at least 80% compliant with the daily e-Diary 'check-ins' in the base study and completed the 2-hour and 4-hour post-dose assessments in the eDiary. Note: If a subject treats their qualifying migraine in the base study within 5 days of randomization (i.e. ≤ 4 daily check-ins should have been completed in the eDiary), they are eligible for this study if they missed 1 daily check-in, even though compliance was \<80%; 2. Participant voluntarily agrees to participate in the study by giving written informed consent; 3. Participant is able to read, understand, and complete the study questionnaires and diary; 4. Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions; 5. Participant is willing to use his/her own personal, qualified smartphone to download any specific eDiary applications for use for the entire duration of the study; 6. For females of reproductive potential (as determined in the base study), continues to agree to remain abstinent from heterosexual activity or a. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the EoS visit. Acceptable methods of birth control are: i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral; injectable; implantable; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence\*; progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods). * Abstinence can be used as the sole method of contraception if it is in line with the participant's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception. Exclusion Criteria: 1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Participants must have a negative urine pregnancy result at the base study EoS/Visit 3 (i.e., pre-randomization for this study); 2. Has, at the time of the base study EoS/Visit 3, had any change in medical history or a laboratory finding since screening in the acute treatment study that in the opinion of the investigator renders the participant unsuitable for this study (e.g., development of a finding that would have precluded participation in the base acute treatment study); 3. Participant is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS) taken during the base study E0S/Visit 3, or of harm to others in the opinion of the investigator. Participants must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in 'since last version' version of the C-SSRS; 4. Participant is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during trial participation) as assessed for the base study E0S/Visit 3; 5. Has any major surgery scheduled for the duration of the trial; 6. Has any other unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with the interpretation of efficacy and/or safety results; 7. At Visit 1, has an open/ongoing adverse event from the base study EoS visit; 8. Experienced a serious adverse event in the base study; 9. Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةTRIPLE (3)
التجنيدمطلوب 1,000 مشارك

الجهة الراعية والمتعاونون

  • Kallyope Inc. الجهة الراعية

الأذرع والتدخلات

  • Elismetrep 10 mgEXPERIMENTAL
  • Elismetrep 20 mgEXPERIMENTAL

التدخلات

  • دواء Elismetrep

    Administered orally

  • دواء Placebo

    Administered orally

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Proportion of participants with at least one treatment-emergent adverse event (TEAE)

    الإطار الزمني Through study completion, an average of 1 year

  2. مقياس النتيجة الأولي

    Proportion of participants with at least one treatment-emergent serious adverse event (SAE)

    الإطار الزمني Through study completion, an average of 1 year

  3. مقياس النتيجة الأولي

    Proportion of participants with TEAEs leading to study drug discontinuation

    الإطار الزمني Through study completion, an average of 1 year

  4. مقياس النتيجة الأولي

    Proportion of participants with TEAEs that occur in at least 5% of treated participants in either treatment arm

    الإطار الزمني Through study completion, an average of 1 year

التواريخ

تاريخ البدء3 أغسطس 2026 (فعلي)
الإتمام الأولي1 يونيو 2028 (تقديري)
الإتمام1 يونيو 2028 (تقديري)
أول نشر29 يونيو 2026 (فعلي)
آخر تحديث27 أغسطس 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةأغسطس 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

113 موقعاً قيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Albuquerque Clinical TrialsAlbuquerqueNew Mexicoقيد التجنيد
Lehigh Center for Clinical ResearchAllentownPennsylvaniaقيد التجنيد
Dent Neuro Institute, BuffaloAmherstNew Yorkقيد التجنيد
Michigan Headache Pain & Neurological InstituteAnn ArborMichiganقيد التجنيد
DelRicht ResearchAtlantaGeorgiaقيد التجنيد
Tekton ResearchAustinTexasقيد التجنيد
FutureSearch Trials of NeurologyAustinTexasقيد التجنيد
Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)BardstownKentuckyقيد التجنيد
Central Research Associates, LLC (CRA) dba Flourish ResearchBirminghamAlabamaقيد التجنيد
Boston Clinical Trials - AlcanzaBostonMassachusettsقيد التجنيد
Pantheon Clinical ResearchBountifulUtahقيد التجنيد
SPRI Clinical Trials, LLCBrooklynNew Yorkقيد التجنيد
IMMUNOe Research CentersCentennialColoradoقيد التجنيد
Crescent City Headache & Neurology CenterChalmetteLouisianaقيد التجنيد
TrialSphereChandlerArizonaقيد التجنيد
OnSite Clinical SolutionsCharlotteNorth Carolinaقيد التجنيد
WR-ClinSearch, LLCChattanoogaTennesseeقيد التجنيد
Chicago Headache Center & Research InstituteChicagoIllinoisقيد التجنيد
Cedar Crosse Research CenterChicagoIllinoisقيد التجنيد
StudyMetrix ResearchCity of Saint PetersMissouriقيد التجنيد
MCB Clinical Research CentersColorado SpringsColoradoقيد التجنيد
Axiom Research, LLCColtonCaliforniaقيد التجنيد
Hometown ResearchColumbusOhioقيد التجنيد
True North NeurologyCommackNew Yorkقيد التجنيد
ProScience Research GroupCulver CityCaliforniaقيد التجنيد
Horizon Clinical Research and Gill NeuroscienceCypressTexasقيد التجنيد
APD Clinical ResearchCypressTexasقيد التجنيد
FutureSearch Trials of Dallas, LPDallasTexasقيد التجنيد
J. Lewis Research, Inc. / Foothill Family Clinic DraperDraperUtahقيد التجنيد
OK Clinical Research, LLCEdmondOklahomaقيد التجنيد
Leading Edge Research LA, LLCEncinoCaliforniaقيد التجنيد
Healthcare Research Network II, LLCFlossmoorIllinoisقيد التجنيد
Advanced Neurosciences ResearchFort CollinsColoradoقيد التجنيد
Guilford Neurologic Research Partners, LLCGreensboroNorth Carolinaقيد التجنيد
Headache Wellness CenterGreensboroNorth Carolinaقيد التجنيد
DelRicht ResearchGulfportMississippiقيد التجنيد
Healthcare Research NetworkHazelwoodMissouriقيد التجنيد
DM Clinical ResearchHoustonTexasقيد التجنيد
Victorium Clinical ResearchHoustonTexasقيد التجنيد
Axiom Research, Orange CountyIrvineCaliforniaقيد التجنيد
AMR Clinical - Kansas CityKansas CityMissouriقيد التجنيد
Clinical Investigation Specialists, Inc.KenoshaWisconsinقيد التجنيد
GMG Clinical Research, LLC dba Radiance Clinical ResearchLampasasTexasقيد التجنيد
Wake Research Las Vegas RainbowLas VegasNevadaقيد التجنيد
IMA Clinical Research - Las VegasLas VegasNevadaقيد التجنيد
Excel Clinical ResearchLas VegasNevadaقيد التجنيد
AMR Clinical - Las VegasLas VegasNevadaقيد التجنيد
Redbird ResearchLas VegasNevadaقيد التجنيد
CTI Clinical Research CenterLexingtonKentuckyقيد التجنيد
AMR Clinical - LexingtonLexingtonKentuckyقيد التجنيد

يُدرَج 63 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 27 أغسطس 2026

    أُزيل موقع

    1 site removed (113 total)

    114113

  2. 6 أغسطس 2026

    تغيّرت الحالة

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  3. 6 أغسطس 2026

    فُتح التجنيد

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  4. 6 أغسطس 2026

    أُزيل موقع

    1 site removed (114 total)

    115114

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07674654